Fluorodyne™ EX grade EDF filters, a Pall Life Sciences product, are 0.2 micron rated high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 107 cfu/cm2 of membrane, Fluorodyne EX grade EDF filters are well suited for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids. AB-style filters are replaceable cartridges used with stainless steel housing assemblies, suitable for medium-to-large-scale manufacturing operations (100 L to > 1000 L), supplied with -226 O-ring (Pall code 2 or code 7) fittings as standard. AB-style filters with Fluorodyne EX grade EDF membrane feature a laid over pleat membrane construction and high effective filtration area (>1 m2 per 10” assembly) for outstanding throughput performance. A validation package supports the assurance of safety within your process. Key features Laid-over pleat filter construction allows for high flow rates and smaller filtration systems Narrow core design for more area Asymmetric built-in prefilter layer for higher dirt-holding capacity Low protein and preservative binding Low extractables Designed for autoclaving or SIP under wet or dry conditions 2D Matrix Marking for electronic traceability via barcode scanner Quality standards All individual filter elements are integrity tested – test correlated to microbial retention Manufactured for use in conformance with cGMP ISO 9000 Certified Quality System Meets USP Biological Reactivity Test in vivo for Class VI-121 °C plastics Every filter tested during manufacture Certificate of Test provided includes -Fabrication Integrity -Bacterial Retention -Materials of construction -Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens